CHAPTER FIVE DISCUSSION
5.2 RECONCILING
redressing global health disparities (cf. Benatar, 2000; Benatar & Singer, 2000; Benatar &
Singer, 2010; Pratt et al., 2013; Shapiro & Benatar, 2005).
Stakeholder understandings likely depend on the time and place of data collection, for example, one could speculate that as HIV care components in low-resource settings have improved, the contrast with care in more resourced settings may appear less stark, and therefore arguments based on reducing-inequities might seem less appealing than a decade ago. No stakeholder in this study grounded researcher responsibilities to help participants with their medical needs in harm-based reasoning, more specifically they did not perceive that researchers should help participants address their HIV needs because the research increases the likelihood that participants will acquire HIV. It is possible that if this study was conducted now among increasing evidence that some vaccine-products increase the likelihood of HIV-acquisition if vaccinees are exposed to HIV (Gray et al., 2014) – even while a biologically plausible mechanism of action is disputed (Michael & Robb, 2014) - then stakeholders may have framed responsibilities in such ways, as found by Haire (2012) in her exploration of microbicide and other prevention trials.
serving the science in non-trivial ways and they sometimes perceived the same response have having both effects.
These findings – both of practices and subjective understandings - suggest that network and site-staff representatives do not occupy a simplistic either-or position of ‘pure scientist’
versus ‘personal physician’ (Richardson & Belsky, 2004, p. 26/27) but are reaching for a more integrated position. They do not see themselves as (nor do they behave as) though they are serving the science exclusively nor as serving patient interests exclusively (Richardson &
Belsky, 2004). These findings suggest that researchers do not adopt (either internally or in their actions) the position of ‘blinkered scientist’ or ‘idealized physician’ (Richardson, 2012c, p. 23) but rather are trying for an intermediate role (cf. Miller et al., 2008) or a middle ground (Dickert et al., 2007) that marries respect for the scientific endeavour with considerations of participant care.
The findings under one sub-theme (‘Taking steps to help’) indicate that - across the needs of HIV, sexual and reproductive health, and even more general medical needs - network and site-staff implemented a range of responses that had very little to do with serving the interests of the research but rather had to do with helping participants to get their needs addressed (such as the network securing money from donors for an HIV treatment fund for HIV needs; or site-staff providing treatment for STIs onsite or site-staff referring participants for private care for general medical ailments while footing the bill). Findings that site-staff implement such helping responses correspond with the results of many prior explorations that document the myriad ancillary-care practices of researchers, including in microbicide trials (Heise et al., 2008; MacQueen & May, 2008; MacQueen et al., 2008; Ramjee et al., 2010); in HIV prevention trials including one vaccine site in South Africa (Ngongo et al., 2012);
in malaria treatment trials (Pratt et al., 2013); and in public health intervention research (Taylor et al., 2011).
All of the afore-mentioned studies provide evidence that research initiatives of many kinds are including the provision of various forms of ancillary care, or implementing various extra- scientific responses for medical needs. These findings suggest at a minimum that vaccine
stakeholders do (and will) accept ethical guidance that requires them to implement some ancillary-care responses.
Three sub-themes set out that many site-staff perceived that when they implemented a response for a scientific reason it might have a real clinical benefit for participants (such as serial monitoring of CD4 counts and viral load leading to early referral for ART). In addition they saw that when they implemented an ancillary-care response it might have a real scientific benefit for the research, such as onsite treatment of ailments as leading to better reporting, and retention. They also perceived that some steps are underpinned by - or located in - both scientific and non-scientific reasons, such as tracking pregnancy outcomes because of fetal safety monitoring and because of a sense of involvement with the pregnant mother (‘understanding steps for science as also helping’, ‘understanding helping steps as soft science’
and ‘understanding steps as for science and helping’)
These stakeholders were not conflating responses implemented for a scientific purpose with responses implemented for a helping purpose or misunderstanding the primary purpose for taking a certain step (cf. Miller & Brody, 2000). This is worth noting because it has been argued that it is problematic when researchers view research from an exclusively therapeutic perspective (Litton, 2006; Miller et al., 1998). Miller et al. (1998) have asserted that it is most unhelpful when investigators adopt justifications for research, and for research procedures, that ‘gloss over’ the principal scientific motivations and that fail to recognise when procedures are intended primarily to generate scientific knowledge and not primarily to benefit participants (p. 1450).
The findings here do not suggest that investigators have fallen prey to the ‘seduction’ of the
‘therapeutic misconception’ (Miller et al., 1998, p. 1451). They did not believe that procedures intended for scientific purposes are being implemented primarily to benefit participants (Appelbaum, Loren, Roth, Lidz, Benson & Winslade, 1987; Miller et al., 1998) but rather they recognised spin-off clinical benefits for participants from research procedures. They seemed to acknowledge that therapeutic benefits may derive from research procedures as part of the context of research but not as the primary purpose of the research (Miller et al., 1998).
This study also showed that site-staff perceived that helping responses can serve to improve scientific outcomes. It is as though these stakeholders augment their justifications for implementing ancillary-care responses on grounds of positive, welfare-promoting reasoning as set out in the first master theme with this additional consideration (which may of course be palatable to research sponsors whose mission is research). Previous empirical explorations have also documented the perspective that ancillary care can inadvertently strengthen recruitment or retention (cf. Heise et al., 2008; Philpott et al., 2010) – which has been referred to some commentators as a soft science justification for ancillary care (Richardson, 2012c).
These meanings attributed by interviewees to their conduct (as well as their actual conduct) indicate efforts to integrate research-related responsibilities with more positive, helping- based responsibilities, and to reduce the tensions between the two. However, this data shows that tensions between science and welfare-promotion remain across HIV, contraception and pregnancy needs (as set out under ‘Understanding some steps for science as not helping’).
More specifically, site-staff viewed some scientific responses (such as inviting participants with HIV onto disease-monitoring protocols, requiring contraceptive compliance for the duration of the study and counselling participants terminate pregnancies) as potentially clashing with helping participants with their important health needs.
These findings resonate with the observation that it is difficult to eliminate potentially competing loyalties between generating important knowledge and promoting participant welfare, and this tension needs careful management (Miller et al., 1998). Current HIV prevention specific ethical guidance does not currently directly speak to the issue that scientific procedures may conflict with perceived best care for participants, even while such conflicts are explicitly recognised for the provision of prevention modalities to participants.
More specifically UNAIDS/WHO (2007; 2012) allows that site-staff may experience conflict between reducing the risk of HIV acquisition (on the one hand) and needing sufficient HIV infections to accrue on efficacy trials (on the other hand). Ethical guidelines may wish to incorporate some text that alerts readers to the potential conflict between serving the science of HIV vaccine trials and serving the interests of participants, which is a point revisited in the next chapter. It may help for each site to have space for careful reflection on this issue,
as part of an internal ancillary-care review, which is a point revisited under recommendations for practice in the next chapter.